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Hologic Announces CE Mark of the Genius™ Digital Diagnostics System for Cervical Cancer Screening

Hologic, Inc. (Nasdaq: HOLX) announced today that its new Genius™ Digital Diagnostics System is now CE marked in Europe. Genius Digital Diagnostics is the first digital cytology platform to combine a new artificial intelligence (AI) algorithm with advanced digital imaging to help cytotechnologists and pathologists identify pre-cancerous lesions and cancer cells in women.

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For more than 30 years, Hologic has developed and brought to market new advances in cervical cancer screening, including the first liquid-based cytology technology, the ThinPrep® Pap Test, and the first FDA-approved mRNA-based HPV test, the Aptima® HPV Assay. Hologic is redefining cervical cancer screening yet again by introducing Genius Digital Diagnostics for laboratories. The system can rapidly analyze all cells on a ThinPrep Pap test slide, narrowing tens of thousands of cells down to a gallery view of the most diagnostically relevant images. This will help provide healthcare providers with the critical information they need to guide earlier detection and better treatment decisions for the patients they serve.

“Application of AI requires digital images that are of exceptional quality,” said Kevin Thornal, president, Diagnostic Solutions Division at Hologic. “Our teams developed a breakthrough imaging technology that converts physical glass cytology slides into digital images with superior clarity. From this digitalization, advanced image analysis and improved standardization are now achievable.”

Genius Digital Diagnostics enables a more seamless and dynamic collaboration across laboratories within a network, connecting pathologists with remote review so each patient can benefit from the collective knowledge of geographically dispersed experts when needed. Digital case review promises to enhance the experience for lab partners by improving workflow and accelerating review time.

“As a part of our development process, we collaborated with cytotechnologists and pathologists to ensure we were developing a new system to meet their needs,” said Michael Quick, vice president, R&D and Innovation at Hologic. “We’re always innovating so we can help our lab partners detect more diseases and save more lives every day.”

Hologic now offers the first CE-marked comprehensive cervical cancer screening portfolio from sample collection to digital diagnosis. Genius Digital Diagnostics consists of a digital imager for image acquisition, an AI algorithm for analyzing images, an image management server for storing images, and a review station for case review. The complete system is scalable, designed to fit the present and future needs of laboratories.

About Hologic

Hologic, Inc. is an innovative medical technology company primarily focused on improving women’s health and well-being through early detection and treatment. For more information on Hologic, visit www.hologic.com .

Forward-Looking Statements

This press release may contain forward-looking information that involves risks and uncertainties, including statements about the use of Hologic’s Genius™ Digital Diagnostics System. There can be no assurance these products will achieve the benefits described herein or that such benefits will be replicated in any particular manner with respect to an individual patient. The actual effect of the use of the products can only be determined on a case-by-case basis depending on the particular circumstances and patient in question. In addition, there can be no assurance that these products will be commercially successful or achieve any expected level of sales. Hologic expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any such statements presented herein to reflect any change in expectations or any change in events, conditions or circumstances on which any such statements are based.

Hologic, Genius Digital Diagnostics, ThinPrep, Aptima and The Science of Sure are registered trademarks of Hologic, Inc. in the United States and/or other countries.

SOURCE: Hologic, Inc.

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